FilmArray RP EZ Control Panel M265 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae on the FilmArray RP EZ assay performed on the FilmArray systems. FilmArray RP Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray RP EZ assay. This product is not intended to replace manufacturer controls provided with the device.

Device Description

FilmArray RP EZ Control Panel M265, P/N M265, is a quality control panel consisting of 2 controls, FilmArray RP EZ Positive Control, P/N M266, and FilmArray RP EZ Negative Control. P/N M267. The Positive Contains non-infectious surrogate control material: a solution of synthetic RNA transcripts in buffers, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the FilmArray RP EZ assay (Table 1. below) on the FilmArray 2.0 EZ Configuration system. The RNA in the Negative Control is non-specific RNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray RP EZ Control Panel M265 is processed separately according to FilmArray RP EZ assay manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

AI/ML Overview

The document describes the FilmArray RP EZ Control Panel M265, an assayed quality control material for clinical microbiology assays. The study aims to demonstrate substantial equivalence to a predicate device by evaluating the performance of the control panel.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the "Correct Positive Control Result" and "Correct Negative Control Result" percentages in the performance studies. While explicit numerical thresholds for acceptance are not stated for each study, the consistently high percentages (often 100% or very close to it) demonstrate that the device met the manufacturer's internal performance expectations for these quality control materials.

Acceptance Criteria (Implied)	Reported Device Performance
Positive Control Performance: All respiratory pathogen analytes in the positive control should be correctly detected.	All Test Results Summary (4 sites - Internal & External): 100% Correct Positive Control Result (129/129 valid tests).External Site Testing (3 sites): 100% Correct Positive Control Result (90/90 valid tests).Within-run Reproducibility: 6/6 correct results for Positive Control Lot A06JAN16A.Lot-to-Lot Testing: 4/4 correct (M40DEC15A), 3/3 correct (A28DEC15A), 4/4 correct (A06JAN16A after 1 invalid retest).Precision Testing: 100% Correct Results for all 3 positive control lots (12/12, 13/13, 14/14 valid tests).
Negative Control Performance: No respiratory pathogens should be detected.	All Test Results Summary (4 sites - Internal & External): 98.6% Correct Negative Control (137/139 valid tests) with 2 incorrect results (false positives).External Site Testing (3 sites): 97.8% Correct Negative Control (88/90 valid tests) with 2 incorrect results (false positives, specifically 2 from Site 3).Within-run Reproducibility: 5/5 correct results for Negative Control Lot M41DEC15A.Precision Testing: 100% Correct Results for all 3 negative control lots (16/16, 16/16, 17/17 valid tests).
Reproducibility (within-run, lot-to-lot, precision): Consistent and correct results across different testing conditions (lots, operators, days).	All reproducibility tests (within-run, lot-to-lot, and precision) reported "All results were correct and reproducible" or 100% correct results for valid tests.

2. Sample Sizes Used for the Test Set and Data Provenance

All Test Results:
- Total Tests: 271 (3 invalid, 268 included in analysis). This includes both internal and external studies.
- Positive Controls: 129 valid tests.
- Negative Controls: 139 valid tests.
- Provenance: Data was generated from an "internal study" at MMQCI (Saco, Maine) and an "external study" at "2 CLIA-waived sites and 1 external site under simulated CLIA-waived conditions." The study appears to be prospective, as it involved manufacturing and testing according to a pre-defined protocol.
External Site Testing:
- Total Tests: 182 (2 invalid, 180 included in analysis).
- Positive Controls: 90 valid tests.
- Negative Controls: 90 valid tests.
- Provenance: Generated from two CLIA-waived clinical settings and one simulated CLIA-waived test setting. Prospective.
Reproducibility (Within-run):
- Positive Control: 6 tests.
- Negative Control: 5 tests.
- Provenance: MMQCI (Saco, Maine). Prospective.
Reproducibility (Lot-to-Lot):
- Total Tests: 12 (1 invalid, 11 included in analysis).
- Provenance: Not explicitly stated but inferred to be similar to other MMQCI internal testing. Prospective.
Precision Testing:
- Total Tests: 89 (1 invalid, 88 included in analysis).
- Positive Controls: 39 valid tests.
- Negative Controls: 49 valid tests.
- Provenance: MMQCI (Saco, Maine). Prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a quality control material, the "ground truth" is typically inherent in the design and formulation of the control itself (e.g., the positive control is designed to be positive for specific targets, and the negative control is designed to be negative for those targets). The performance of the control is then verified against the expected outcome using the diagnostic assay it's intended to monitor. The document describes how the control panel was formulated (synthetic RNA transcripts for positive control, non-specific RNA for negative control).

4. Adjudication Method for the Test Set

This information is not explicitly provided. The testing results indicate some "invalid" results due to "internal control pouch failures" which were excluded and re-tested. This implies a protocol for handling such technical failures but does not describe an adjudication method by experts for discrepancies in the detection of analytes. Given that this is a quality control device's performance assessment, results are binary (detected/not detected) against a known composition, so expert adjudication for ground truth may not be relevant in the same way as for diagnostic devices analyzing patient samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses human reader performance with and without an AI system for diagnostic tasks. This device is a quality control material, not a diagnostic AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence. The entire study describes the "standalone" performance of the FilmArray RP EZ Control Panel M265 when processed by the FilmArray RP EZ assay on the FilmArray systems. While human operators are involved in running the tests, the performance being measured is of the control material itself, validating its ability to produce expected results. There is no "human-in-the-loop" AI involved here; it's about the control material's interaction with a diagnostic assay.

7. The Type of Ground Truth Used

The ground truth for this device is based on the known synthetic composition of the control panel.

Positive Control: Composed of synthetic RNA transcripts corresponding to all respiratory pathogens detected by the FilmArray RP EZ assay. The ground truth is that these specific targets should be detected.
Negative Control: Composed of non-specific RNA. The ground truth is that the target respiratory pathogens should not be detected.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this document. This device is a quality control material, not an algorithm that requires a "training set" for machine learning. The studies described are validation and performance testing of a physical product.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/not provided as there is no "training set" for this quality control material. The ground truth is established by the controlled, synthetic formulation of the positive and negative controls themselves.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

September 2, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, ME 04072

Re: K161573

Trade/Device Name: FilmArray RP EZ Control Panel M265 Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II (Special Controls) Product Code: PMN Dated: June 6, 2016 Received: June 7, 2016

Dear Ms. Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

{1}------------------------------------------------

Page 2 - Ms. Gordon

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Steven R. Gitterman -S

for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161573

Device Name FilmArray RP EZ Control Panel M265

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of maroon and yellow. The "MM" and "CI" are in maroon, while the "Q" is in yellow. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller font size. A yellow brushstroke-like design is on the left side of the logo.

23 Mill Brook Road Mill Brook Business Park Saco, Maine 04072 www.mmaci.com Phone: 207-885-1072 Fax: 207-885-1079

510 (k) Summary

510(k) Number: K161573

Purpose for submission: New product

Applicant Information:

Applicant:	Maine Molecular Quality Controls, Inc.
Address:	23 Mill Brook RoadSaco, Maine 04072

Contact Person:	Joan Gordon, President MMQCI
Phone:	207-885-1072 extension 201
Fax:	207-885-1079
Email Address:	jgordon@mmqci.com

Preparation Date: May 31, 2016

Device

Device Trade Name:	FilmArray RP EZ Control Panel M265, model M265
Device Common Name:	Quality Control Material for Microbiology Assays
Device Type:	Assayed quality control material for clinical microbiology assays
Class:	Class II (Special controls)
Regulation:	21 CFR 866.3920
Panel:	Microbiology - 83
Product code:	PMN

Predicate Device

DEN150058; Amplichek II, Bio-Rad Laboratories

Device Description

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the acronym "MMQCI" in bold, dark red letters. Below the acronym, the full name of the company, "Maine Molecular Quality Controls, Inc.," is written in a smaller, lighter font. A stylized, abstract graphic in shades of yellow and gold is positioned to the left of the text, adding a visual element to the logo.

(NPS) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

Respiratory Pathogens
Adenovirus	Influenza A H1-2009
Coronavirus	Influenza B
Human Metapneumovirus	Parainfluenza Virus
Human Rhinovirus/ Enterovirus	Respiratory Syncytial Virus
Influenza A	Bordetella pertussis
Influenza A subtype H1	Chlamydophila pneumoniae
Influenza A subtype H3	Mycoplasma pneumoniae

Table 1. Respiratory pathogens detected by FilmArray RP EZ assay

Device Intended Use

FilmArray RP EZ Control Panel M265 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae on the FilmArray RP EZ assay performed on the FilmArray systems. FilmArray RP Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray RP EZ assay. This product is not intended to replace manufacturer controls provided with the device.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a serif font, with "MM" in a larger size and a darker color than "QCI". Below the letters, the full name of the company is written in a smaller font. To the left of the letters, there is an abstract design in yellow, resembling a brush stroke or a stylized wave.

Characteristic	Candidate Device:FilmArray RP EZControl Panel M265(K161573)	Predicate DeviceAmplichek II(DEN150058)
Intended Use	External assayed qualitycontrol to monitor in vitrolab nucleic acid test	Same
Physical format	Ready-to-Use Liquid	Same
Directions for Use	Process like patient sample	Same
Composition	Synthetic RNA transcripts	Intact microorganisms
Assay Steps Monitored	Extraction, reversetranscription,amplification, detection,identification	Same except does notmonitor extraction(new device notencapsulated)
Number of targetsmonitored in one assay	Multiple	Same

Substantial Equivalence

Summary Performance Data

All Test Results

Three lots of FilmArray RP EZ Control Panel M265, FilmArray RP EZ Positive Control and FilmArray RP EZ Negative Control, were manufactured and tested using the FilmArray RP EZ assay on the FilmArray instrument 2.0 EZ Configuration system to confirm performance. The lots were manufactured incorporating variables including multiple key component lots, different operator and different days over four months.

An internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over multiple days with 4 reagent lots by one operator. An external study was performed to assess the ability of the intended user to test the FilmArray RP EZ Control Panel M265 in a CLIA-waived setting. The external performance study tested the 3 lots of FilmArray RP EZ Control Panel M265 at 2 CLIA-waived sites and 1 external site under simulated CLIA-waived conditions over a period of 10 days using 3 FilmArray reagent lots, incorporating multiple operators.

All FilmArray RP EZ Positive Control respiratory pathogen analytes were correctly detected in the internal and external study (Correct Positive Control Result). All but 2 FilmArray RP EZ Negative Controls gave Correct Negative Control Results of no respiratory pathogens detected. There were 3 Invalid results caused by internal control pouch failures and 2 false positive results. It is not possible to determine the cause of the 2 false positive results. However, since the results were from 2 different control lots and 2 different pouch lots at the same testing site, environmental contamination is possible, especially since testing occurred during flu season.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of maroon and yellow colors. The word "MAINE MOLECULAR QUALITY CONTROLS, INC." is written in a smaller font size below the letters. A yellow, curved design element is placed behind the letters, adding a visual flair to the logo.

Table 1. Summary of All Test Results
Numberof sites	TotalTests	Invalid	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrect*PositiveControl	CorrectNegativeControlResult	IncorrectNegativecontrolResult	PercentCorrect*NegativeControl
4	271	3	129	0	100%	137	2	98.6%

*The 3 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.

External Site Testing

Three lots of FilmArray RP EZ Control Panel M265, FilmArray RP EZ Positive Control and FilmArray RP EZ Negative Control, were manufactured by MMQCI. They were tested by the FilmArray RP EZ assay on the FilmArray instrument 2.0 EZ Configuration system at two CLIAwaived clinical settings and one simulated CLIA-waived test setting where users were screened to have training and educational backgrounds consistent with those in the CLIA-waived testing environment.

Testing consisted of three positive and three negative controls run per day, and spanned a period of 10 days (total of 60 control runs per site). Multiple operators participated in testing at each of the three locations. Three lots each of external control material and three lots of RP EZ pouches were tested across all sites.

A total of 182 external controls were tested (91 positive and 91 negative). Two tests were excluded from final data analysis due to Invalid results caused by internal pouch control failures. Data for the remaining 180 control tests are shown below.

Table 2. Summary of External Test Results for 3 Control Lots
ExternalSite	TotalTests	Invalid	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrect*PositiveControl	CorrectNegativeControlResult	IncorrectNegativecontrolResult	PercentCorrect*NegativeControl
1	61	1	30	0	100%	30	0	100%
2	61	1	30	0	100%	30	0	100%
3	60	0	30	0	100%	28	2	93.3%
All Sites	182	2	90	0	100%	88	2	97.8%

*The 2 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a serif font, with the "MM" in a larger size than the "QCI". The words "MAINE MOLECULAR QUALITY CONTROLS, INC." are written in a smaller font below the letters. A yellow brush stroke design is on the left side of the logo.

Reproducibilitv

NOTE: The FilmArray 2.0 is a random access instrument. Therefore, 'runs' refer to replicates tested on the same day.

Within-run Testing: Within-run reproducibility was demonstrated by 1 operator testing 2 lots of FilmArray RP EZ Control Panel M265 with 1 lot of FilmArray RP EZ pouches on the FilmArray 2.0, each within one day. All results were correct and reproducible.

Table 3. Summary of Within-run Reproducibility Results
Control	Control Lot#	No. of Tests	Date of Testing	Pouch Lot	Correct Results
FilmArray RP EZ Positive Control	A06JAN16A	6	1-7-16	239115	6/6
FilmArray RP EZ Negative Control	M41DEC15A	5	12-31-15	239115	5/5

Lot-to-Lot Testing: Lot-to-lot reproducibility was demonstrated by testing 3 lots of FilmArray RP EZ Positive Control using the same pouch lot. All results were correct and reproducible.

Control Lot #	Number of Tests	Pouch Lot	Correct Results
M40DEC15A	4	238915	4/4
A28DEC15A	3	238915	3/3
A06JAN16A	5 (1 Invalid)	238915	4/4

Precision Testing: Precision was demonstrated by testing 3 lots of FilmArray RP EZ Positive Control and 3 lots of FilmArray RP EZ Negative Control at MMQCI over multiple days with 4 reagent lots by one operator using one FilmArray 2.0 instrument. All FilmArray RP EZ Positive Control respiratory pathogen analytes were correctly detected. One test was excluded from final data analysis due to Invalid results caused by an internal pouch control failure.

Table 5. Summary of Precision Testing for 3 Control Lots at MMQCI
Control	Control Lot #	No. ofTests	Invalid	CorrectResults	IncorrectResults	PercentCorrect*
FilmArray RP EZ Positive Control	M40DEC15A	12	0	12	0	100%
FilmArray RP EZ Positive Control	A28DEC15A	13	0	13	0	100%
FilmArray RP EZ Positive Control	A06JAN16A	15	1	14	0	100%
FilmArray RP EZ Negative Control	A29OCT15B	16	0	16	0	100%
FilmArray RP EZ Negative Control	M41DEC15A	16	0	16	0	100%
FilmArray RP EZ Negative Control	A04JAN16A	17	0	17	0	100%
	TOTAL	89	0	88	0	100%

*The Invalid sample was re-tested according to BioFire instructions and was not included in the Percent Correct analysis.

Regulation Number and Section

§ 866.3920 Assayed quality control material for clinical microbiology assays.

(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”